VAPR 227252Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705009664), received between Jun 4, 2018 and Jun 7, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delamination” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K082643); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2018Material Fragmentation; Material Fragmentation

  IT WAS REPORTED VIA EMAIL FROM THE SALES REP THAT DURING A KNEE PROCEDURE, SMALL BITS OF BLACK PLASTIC COATING WAS COMING OFF OF THE VAPR TEMPERATURE CONTROL END EFFECT ELECTRODE TIP WHILE INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED. THERE WAS AN EIGHT MINUTE DELAY WITH NO PATIENT CONSEQUENCES. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578644 ↗
• MalfunctionJun 4, 2018Delamination; Delamination

  IT WAS REPORTED VIA EMAIL FROM THE SALES REP THAT DURING A KNEE PROCEDURE, SMALL BITS OF BLACK PLASTIC COATING WAS COMING OFF OF THE VAPR TEMPERATURE CONTROL END EFFECT ELECTRODE TIP WHILE INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED. THERE WAS A FIVE MINUTE DELAY WITH NO PATIENT CONSEQUENCES. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 7566254 ↗
• MalfunctionJun 4, 2018Flaked; Flaked

  IT WAS REPORTED VIA EMAIL FROM THE SALES REP THAT DURING A KNEE PROCEDURE, SMALL BITS OF BLACK PLASTIC COATING WAS COMING OFF OF THE VAPR TEMPERATURE CONTROL END EFFECT ELECTRODE TIP WHILE INSIDE THE PATIENT. THE FRAGMENTS WERE REMOVED. THERE WAS AN EIGHT MINUTE DELAY WITH NO PATIENT CONSEQUENCES. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 7565539 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082643. One submission often covers many models, so check the product and lot details in each record.

• Z-0133-2013 · Mar 12, 2012 · Terminated
  DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency Syste
• Z-2301-2010 · Jun 7, 2010 · Terminated
  Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and V